Use Lay Language. HA Score to Identify Myeloma Patients Who Could Benefit From HDACi Treatment
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|ClinicalTrials.gov Identifier: NCT03515915|
Recruitment Status : Unknown
Verified April 2018 by University Hospital, Montpellier.
Recruitment status was: Recruiting
First Posted : May 4, 2018
Last Update Posted : May 11, 2018
Panobinostat is a potent oral histone deacetylase inhibitor that alters gene expression through epigenetic mechanisms and inhibits protein degradation. It was recently approved by the US Food and Drug Administration for use in combination with bortezomib and dexamethasone in patients with relapsed multiple myeloma (MM) who have received ≥ 2 prior regimens, including bortezomib and an immunomodulatory drug.
A GEP-based histone acetylation score allowing identification of MM patients with a poor prognosis and who could benefit from HDACi treatment was recently reported(Moreaux et al. BJC. 2013).
Our hypothesis is that the histone acetylation score could be promising to identify MM patients who could benefit from treatment with HDACi and the development of personalized treatment.
|Condition or disease|
|Patients With Recurrent or Refractory Multiple Myeloma|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Evaluating the Interest of GEP-based Derived Histone Acetylation Score to Identify Myeloma Patients Who Could Benefit From Treatment With HDAC Inhibitor|
|Actual Study Start Date :||April 23, 2018|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2019|
- Overall Response Response rate 'ORR', PR and better (as per IMWG criteria) of MM patients after treatment with Panobinostat according to histone acetylation score value [ Time Frame: 1 day ]Overall Response Response rate 'ORR', PR and better (as per IMWG criteria) of MM patients after treatment with Panobinostat according to histone acetylation score value
- Progression free survival will be monitored. [ Time Frame: 1 day ]Progression free survival will be monitored.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515915
|Contact: JEROME MOREAUX, PhD||467337903 ext email@example.com|
|Montpellier, France, 34295|
|Contact: JEROME MOREAUX, PhD 467337903 ext 33 firstname.lastname@example.org|
|Study Director:||JEROME MOREAUX, PhD||University Hospital, Montpellier|